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Pharmacovigilance / «Citizens»

Benefit-risk balance of certain linear gadolinium agents no longer favourable

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed its previous conclusion from March 2017 that there is convincing evidence of gadolinium deposition in brain tissues following use of gadolinium contrast agents.

No specific conditions linked to gadolinium deposition in the brain have been identified, but the clinical consequences are unknown.

More information on the following link:

Gadolinium-containing contrast agents

Restrictions are provisional measures while review of liver safety is ongoing

The European Medicines Agency (EMA) is provisionally restricting the use of the multiple sclerosis medicine Zinbryta (daclizumab) to patients with highly active relapsing disease that has failed to respond to certain other treatment, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines.

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EMA restricts use of multiple sclerosis medicine Zinbryta

The PRAC has concluded that there is no evidence of a change in the known risk of neutropenic enterocolitis in the European Union (EU) after treatment with docetaxel, a cancer medicine.

Neutropenic enterocolitis is a serious inflammatory condition of the intestine which is known to occur in up to 1 in 1,000 cancer patients taking the medicine.

Having considered available data on docetaxel, the Committee concluded that the recent rise in reporting of the condition observed in France could be due to increased awareness among healthcare professionals. Reporting rates in the EU as a whole do not provide any evidence of an increase in the incidence of neutropenic enterocolitis.

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PRAC concludes there is no evidence of a change in known risk of neutropenic enterocolitis with docetaxel

Review follows case of fulminant liver failure

The European Medicines Agency (EMA) has started a review of the medicine Zinbryta (daclizumab) used to treat adults with relapsing forms of multiple sclerosis (a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord). The review follows the death from fulminant liver failure of a patient who was treated with Zinbryta in an ongoing observational study, as well as four cases of serious liver injury.

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EMA reviews multiple sclerosis medicine Zinbryta

At its May meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of factor VIII medicines to evaluate the risk of developing inhibitors in patients with haemophilia A who have not previously been treated with these medicines.

Factor VIII is needed for blood to clot normally and is lacking in patients with haemophilia A. Factor VIII products replace the missing factor VIII and help control bleeding. However the body may develop inhibitors as a reaction to these medicines, particularly in patients starting treatment for the first time. This can block the effect of these medicines, so bleeding is no longer controlled.

The review was started following publication of a study which concluded that inhibitors develop more frequently in patients receiving recombinant factor VIII medicines than in those receiving plasma-derived factor VIII medicines. The PRAC concluded that there is no clear and consistent evidence of a difference in inhibitor development between the two classes of factor VIII medicines.

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PRAC concludes there is no clear and consistent evidence of a difference in inhibitor development between classes of factor VIII medicines

EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorisations for four linear gadolinium contrast agents because of evidence that small amounts of the gadolinium they contain are deposited in the brain.

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PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing the safety of Uptravi (selexipag), following the deaths of 5 patients taking the medicine in France. Based on a preliminary review of available data, EMA advises that Uptravi may continue to be used, but use must be in line with the current prescribing information.

The PRAC will further explore all available data. Once the review is completed, final conclusions will be published.

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EMA reviewing safety of Uptravi for pulmonary arterial hypertension (updated)

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is warning that an increase in cases of lower limb amputation (mostly affecting the toes) has been observed in patients taking the type 2 diabetes medicine canagliflozin compared with those taking placebo (a dummy treatment) in two clinical trials, CANVAS and CANVAS-R. The studies, which are still ongoing, involved patients at high risk of heart problems.

More information on the following link:

PRAC concludes that diabetes medicine canagliflozin may contribute to risk of toe amputation

EMA reviews diabetes medicine canagliflozin

Review follows data on toe amputations in ongoing study

The European Medicines Agency (EMA) has started a review of the diabetes medicine canagliflozin after an increase in amputations, mostly affecting toes, was observed in an ongoing clinical trial called CANVAS. Cases of lower limb amputation occurred in both the canagliflozin and placebo groups in the trial and the possibility that canagliflozin increases lower limb amputations is currently not confirmed. EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has requested more information from the company to assess whether canagliflozin causes an increase in lower limb amputations and whether any changes are needed in the way this medicine is used in the EU.

More information on this is included in the hyperlink below:

EMA reviews diabetes medicine canagliflozin

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